Postoperative PainPoppiNCT07856615
Postoperative Pain in Infants
An observational study of Postoperative Pain, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
This observational study aims to evaluate skin conductance measurement (SCM) for pain assessment in postoperative newborns. Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation… Read more about this study
- Who is it for?
- Ages 22 weeks and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 30 Oct 2026to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates receiving postoperative care in a tertiary neonatal intensive care unit.
Who may be able to join
- Neonates admitted to the NICU
- Undergoing surgical intervention
- Receiving postoperative care at the study site
Who cannot join
- Lack of parental consent (if applicable)
- Major congenital conditions affecting autonomic nervous system function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Uppsala University Hospital
Uppsala
Johanna Tidehag Walan, Medical Doctor, PhD-student, 704184255, johanna.walan@uu.se
Richard Sindelar, Professor, richard.sindelar@uu.se
About this study
Official title: Assessment of Pain Using Skin Conductance Monitoring in Postoperative Neonates
This observational study aims to evaluate skin conductance measurement (SCM) for pain assessment in postoperative newborns.
Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters.
Read more
Skin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care on postoperative pain.
The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.
Read the detailed description
Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.
Currently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.
Skin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.
In this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.
Additional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.
The study is purely observational, and no interventions beyond standard clinical care will be introduced.
- Conditions
- Postoperative Pain
- Keywords
- skin conductance monitoring, postoperative pain, neonate, preterm infant
- Medical subject headings
- Pain, Postoperative, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance to N-PASS score correlation
Correlation between skin conductance measurements and N-PASS scores and vital parameters during the postoperative period
Measured: 72-80 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Tidehag Walan, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856615
- Sponsor's protocol ID
- Dnr 2026-01844-01
- Acronym
- Poppi
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain Using Skin Conductance Monitoring in Postoperative Neonates
- ClinicalTrials.gov ID
- NCT07856615
- Acronym / sponsor ID
- Poppi / Dnr 2026-01844-01
- Conditions
- Postoperative Pain
- Keywords
- skin conductance monitoring, postoperative pain, neonate, preterm infant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to evaluate skin conductance measurement (SCM) for pain assessment in postoperative newborns.
Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters.
Skin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care on postoperative pain.
The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.
Detailed description
Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.
Currently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.
Skin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.
In this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.
Additional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.
The study is purely observational, and no interventions beyond standard clinical care will be introduced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates receiving postoperative care in a tertiary neonatal intensive care unit.
Key inclusion criteria (3 listed)
- Neonates admitted to the NICU
- Undergoing surgical intervention
- Receiving postoperative care at the study site
Key exclusion criteria (2 listed)
- Lack of parental consent (if applicable)
- Major congenital conditions affecting autonomic nervous system function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin conductance to N-PASS score correlation
Time frame: 72-80 hours after surgery
Correlation between skin conductance measurements and N-PASS scores and vital parameters during the postoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance to N-PASS score correlation (time frame: 72-80 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.